Lawrence Maggie, Davis Bridget, Clark Naomi E, Booth Jo, Donald Graeme, Dougall Nadine, Grealy Madeleine, Jani Bhautesh, MacDonald Jennifer, Mason Helen, Maxwell Margaret, Parkinson Ben, Pieri Matilde, Wang Xu, Mercer Stewart
Research Centre for Health (ReaCH), Glasgow Caledonian University (GCU), Glasgow, Scotland, G4 0BA, UK.
School of Health and Society, University of Salford, Salford, M6 6PU, UK.
Pilot Feasibility Stud. 2024 Sep 12;10(1):119. doi: 10.1186/s40814-024-01545-w.
Depression and anxiety are prevalent after stroke and associated with poor outcomes. We previously co-developed a stroke-specific self-management intervention, HEADS: UP (Helping Ease Anxiety and Depression after Stroke). The two studies reported here aimed to test the feasibility and acceptability of the HEADS: UP course and supporting materials, and research processes ahead of a definitive trial.
We recruited community-dwelling stroke survivors (SS) ≥ 3 months post-stroke, with symptoms of mood disorder (Hospital Anxiety and Depression Scale ≥ 8). Participants could 'enrol' a family member/ 'other' to take part with them, if desired. Study 1 tested HEADS: UP delivered in-person, and informed optimisation of research processes and intervention delivery and materials. In a pragmatic response to Covid-related socialising restrictions, HEADS: UP was then adapted for online delivery, tested in Study 2. The primary outcome (both studies) was the feasibility (acceptability, fidelity) of the intervention and of research processes. Quantitative data (including patient-reported outcome measures (PROMs) assessing mood and quality of life) and qualitative data were collected pre-/post-intervention. Descriptive statistics were used to analyse quantitative data; a thematic framework approach was used to analyse qualitative data. Both studies received ethical approval prior to commencement.
Study 1 Feasibility: 13 (59.1%) of 22 potentially eligible stroke survivors consented; aged 66 (median, interquartile range (IQR) 14); male (n = 9; 69%); 28 (IQR 34) months post-stroke. Of these, n = 10 (76.9%) completed PROMS pre-intervention; n = 6 (46.2%) post-intervention. Acceptability: Nine (69.2%) of the 13 participants attended ≥ 4 core intervention sessions. Aspects of screening and data collection were found to be burdensome. Study 2 Feasibility: SS n = 9 (41%) of 22 potentially eligible stroke survivors consented; aged 58 years (median; IQR 12); male (n = 4; 44.4%); 23 (IQR 34) months post-stroke. Of these, n = 5 (55.6%) completed PROMS pre-intervention; n = 5 (55.6%) post-intervention. Acceptability: Five (55.6%) of the 9 participants attended ≥ 4 core sessions. They found online screening and data collection processes straightforward.
抑郁症和焦虑症在中风后很常见，且与不良预后相关。我们之前共同开发了一种针对中风的自我管理干预措施，即“振作起来（HEADS: UP）（帮助缓解中风后的焦虑和抑郁）”。这里报告的两项研究旨在测试“振作起来”课程及辅助材料的可行性和可接受性，以及在进行确定性试验之前的研究过程。
我们招募了中风后至少3个月的社区中风幸存者（SS），他们有情绪障碍症状（医院焦虑抑郁量表≥8）。如果愿意，参与者可以“招募”一名家庭成员/“其他人”与他们一起参与。研究1测试了面对面授课的“振作起来”课程，并为研究过程、干预授课及材料的优化提供依据。为切实应对与新冠疫情相关的社交限制，“振作起来”课程随后调整为线上授课，并在研究2中进行测试。主要结局指标（两项研究均采用）是干预措施及研究过程的可行性（可接受性、保真度）。在干预前后收集定量数据（包括评估情绪和生活质量的患者报告结局指标（PROMs））和定性数据。采用描述性统计分析定量数据；采用主题框架法分析定性数据。两项研究在开始前均获得了伦理批准。
研究1可行性：22名潜在合格的中风幸存者中有13名（59.1%）同意参与；年龄66岁（中位数，四分位间距（IQR）14）；男性（n = 9；69%）；中风后28个月（IQR 34）。其中，n = 10（76.9%）在干预前完成了PROMs；n = 6（46.2%）在干预后完成。可接受性：13名参与者中有9名（69.2%）参加了≥4次核心干预课程。发现筛查和数据收集方面很繁琐。研究2可行性：22名潜在合格的中风幸存者中有9名（41%）同意参与；年龄58岁（中位数；IQR 12）；男性（n = 4；44.4%）；中风后23个月（IQR 34）。其中，n = 5（55.6%）在干预前完成了PROMs；n = 5（55.6%）在干预后完成。可接受性：9名参与者中有5名（55.6%）参加了≥4次核心课程。他们发现线上筛查和数据收集过程很简单。
